Oral liquids monograph Flashcards
Liquid preparations for oral use are usually
solutions, emulsions or suspensions containing one or more active substances in a suitable vehicle; they may, however, consist of liquid active substances used as such (oral liquids).
Some preparations for oral use are prepared by
dilution of concentrated liquid preparations, or from powders or granules for the preparation of oral solutions or suspensions, for oral drops or for syrups, using a suitable vehicle.
Liquid preparations for oral use may contain
antimicrobial preservatives, antioxidants and other excipients such as dispersing, suspending, thickening, emulsifying, buffering, wetting, solubilising, stabilising, flavouring and sweetening agents and colouring matter, authorised by the competent authority.
Emulsions may show evidence of
phase separation but are readily redispersed on shaking. Suspensions may show a sediment, which is readily dispersed on shaking to give a suspension that remains sufficiently stable to enable the correct dose to be delivered.
Several categories of oral liquid preparations may be distinguished
— oral solutions, emulsions and suspensions;
— powders and granules for oral solutions and suspensions;
— oral drops;
— powders for oral drops;
— syrups;
— powders and granules for syrups.
During development of an oral liquid, it must be demonstrated that
the nominal content can be withdrawn from the container, for liquid preparations for oral use presented in single-dose containers.
In the manufacturing, packaging, storage and distribution of liquid preparations for oral use, suitable measures are taken to ensure
microbial quality
In the manufacture of liquid preparations for oral use containing dispersed particles, measures are taken to ensure
a suitable and controlled particle size with regard to the intended use.
Oral liquid tests
Uniformity of dosage units
Uniformity of content
Uniformity of mass
Single-dose preparations that are solutions comply with the following test: weigh individually the contents of 20 containers, emptied as completely as possible, and determine the average mass. Not more than 2 of the individual masses deviate by more than 10 per cent from the average mass and none deviate by more than 20 per cent.
Dose and uniformity of dose of oral drops
Into a suitable graduated cylinder, introduce by means of the dropping device the number of drops usually prescribed for one dose, or introduce by means of the measuring device the usually prescribed quantity. The dropping speed does not exceed 2 drops per second. Weigh the liquid, repeat the addition, weigh again and carry on repeating the addition and weighing until a total of 10 masses are obtained. No single mass deviates by more than 10 per cent from the average mass.
If the labelling defines a mass, the total of 10 masses does not differ by more than 15 per cent from the nominal mass of 10 doses defined on the labelling. If the labelling defines a volume, measure the total volume of 10 doses. The volume does not differ by more than 15 per cent from the nominal volume of 10 doses defined on the labelling.
Uniformity of mass of delivered doses from multidose containers
Liquid preparations for oral use supplied in multidose containers comply with the test. Oral drops are not subject to the provisions of this test.
Oral liquid labelling
The label states the name of any added preservative.
POWDERS AND GRANULES FOR ORAL SOLUTIONS AND SUSPENSIONS - tests
Uniformity of dosage units
Uniformity of content
Uniformity of mass
POWDERS AND GRANULES FOR ORAL SOLUTIONS AND SUSPENSIONS - labelling
The label states:
— the method of preparation of the solution or suspension;
— the conditions and the duration of storage after reconstitution.
